Invasive intracranial pressure (ICP) monitoring is highly effective, but involves risks. HS-1000 measures ICP non-invasively by assessing the acoustic properties of the patient's head. HS-1000 device, a proprietary new non-invasive ICP monitor, is expected to safely and accurately monitor ICP with minimal discomfort to patients, and provide information about normal or elevated ICP levels to the physicians. The study objective is to compare the accuracy and safety profile of HS-1000, a non-invasive ICP monitor, to invasive ICP monitoring via an external ventricular drain (EVD)
HS-1000 device, a proprietary new non-invasive ICP monitor, is expected to safely and accurately monitor ICP with minimal discomfort to patients, and provide information about normal or elevated ICP levels to the physicians
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
100
ICP monitoring will be done in parallel for both HS-1000 and ICP monitoring via an EVD device (per clinical protocol without any change in the patient's management). HS-1000 ICP monitoring intervals will last from 30 minutes to 6 hours, continuously depending on the patient's clinical condition. Each such interval may occur three times a day or more depending on the clinical condition of the patient.
University of Miami Hospital
Miami, Florida, United States
NOT_YET_RECRUITINGUniversity of Maryland Medical Center
Baltimore, Maryland, United States
RECRUITINGSinai Hospital
Baltimore, Maryland, United States
NOT_YET_RECRUITINGThe Johns Hopkins Hospital
Baltimore, Maryland, United States
NOT_YET_RECRUITINGMetro Health
Cleveland, Ohio, United States
NOT_YET_RECRUITINGErlangen University
Erlangen, Germany
RECRUITINGKlinikum Stuttgart
Stuttgart, Germany
NOT_YET_RECRUITINGPost-hoc algorithm processing to compare ICP values (mmHg) of the HS-1000 device and invasive ICP monitor collected in each ICP monitoring cycle
Time frame: 2 months after last patient \ last visit
Incidence of AEs through 48 hours from end of ICP monitoring with HS-1000 device
Time frame: 48 hours from end of ICP monitoring
Rate of ear infections/irritations coded and graded using the adapted CTCAE dictionary provided to the site Principal Investigator (PI)
Time frame: 48 hours from end of ICP monitoring
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